CN101612357A - A kind of Chinese medicine composition for the treatment of tumor and preparation method thereof - Google Patents

A kind of Chinese medicine composition for the treatment of tumor and preparation method thereof Download PDF

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CN101612357A
CN101612357A CN200910008916A CN200910008916A CN101612357A CN 101612357 A CN101612357 A CN 101612357A CN 200910008916 A CN200910008916 A CN 200910008916A CN 200910008916 A CN200910008916 A CN 200910008916A CN 101612357 A CN101612357 A CN 101612357A
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semen strychni
rev
alumen
chinese medicine
medicine composition
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CN101612357B (en
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谢炘
孟同凤
胡亚军
杜宏伟
杜德平
李桂桂
邓玉清
吕荷
赵仁芝
李瑛�
何莉
汤辅豪
佟畹兰
雷宁霞
孙艳霞
邵元生
董明芝
沈晓红
吴春霞
许志红
张旭香
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Xi'an Cp Pharmaceutical Co Ltd
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Abstract

The invention provides a kind of Chinese medicine composition for the treatment of tumor and preparation method thereof.This Chinese medicine composition is to be made by Radix Curcumae, Herba Agrimoniae, Oletum Trogopterori, Alumen, Sal Nitri, Resina Toxicodendri, Fructus Aurantii, Semen Strychni Pulveratum, Semen Strychni Pulveratum wherein is to be made by following bulk drugs: Semen Strychni (processed), adjuvant, described adjuvant are selected from one or more mixing in dextrin, starch, mannitol, microcrystalline Cellulose, the calcium bicarbonate.Pharmaceutical composition of the present invention has the body resistance strengthening and constitution consolidating, and effects such as heat-clearing and toxic substances removing can be regulated body's immunity, alleviate toxicity, and cancer preventing and treating combines, and has improved the oncotherapy effect.

Description

A kind of Chinese medicine composition for the treatment of tumor and preparation method thereof
Technical field
The present invention relates to field of medicaments, particularly relate to a kind of Chinese medicine composition for the treatment of tumor and preparation method thereof.
Background technology
Tumor, be normal cell that growing in the human body or sophisticated under different factor long terms, occur that hyperplasia becomes unusual differentiation and the neoplasm that forms.It is different with normal structure and cell, not according to Normocellular metabolism rule growth, and becomes unfettered and control. and be irregular ramp. so that can destroy the structure of normal structure organ and influence its function.Tumor cell is compared with normal cell, and structure, function and metabolic unusual are arranged, and they have paranormal hypertrophy ability, and this hypertrophy and body are not in tune.Non-neoplastic hyperplasia is different with neoplastic hyperplasia, and the former often has tangible stimulating factor, and hypertrophy is limited to a certain degree and certain hour, in case this factor eliminate, i.e. hypertrophy no longer, but as surmount certain limit, qualitative change takes place, then also can be changed into neoplastic hyperplasia.Malignant cell can also be soaked into towards periphery and spread, even diffusion transfer continues to increase exponentially to other organ-tissues, causes human body or life are endangered greatly.The partes corporis humani position is by different cells and organizational composition, except that hair, tooth with refer to that (toe) first, tumor can take place for nearly all organ and tissue, cell.Therefore, tumor is not a kind of simple disease, but-disease of big class complexity, it is characterized by paracytic growth out of control, and send out to its place by former position, this sending out as uncontrollable will be invaded critical organ and be caused depletion, cause death at last.The different tumor of kind more than 400 approximately can take place in human body, and the cancer that it has often been said is exactly a malignant tumor, and in fact this is the general name of a big class disease.Malignant tumor belongs to categories such as the traditional Chinese medical science " rock ", " gathering ", and empty earlier because of healthy energy, the exopathogen of being detained, qi stagnation blood stasis, evil poison gather in bulk and form.It should be noted that the crude drug of some treatment tumors commonly used at present, as Radix Aconiti, Radix Aconiti Kusnezoffii, Semen Strychni etc., self promptly having has certain toxicity, and long-term or excessive use easily causes poisoning, even threat to life, thereby highly necessary careful when using, can not be excessive, so as to avoid an accident.Semen Strychni is the dry mature seed of loganiaceae plant Semen Strychni Strychnos nux-vomica L. or Yunnan Semen Strychni Strychnos pierriana A.W.Hill.The mature fruit of gathering winter is taken out seed, dries.Semen Strychni nature and flavor hardship, temperature; Very toxic, return liver, spleen channel.It has removing obstruction in the collateral to relieve pain, mass dissipating and swelling eliminating.Safe, effective, quality controllable is the fundamental of a medicine of overall merit.But because characteristics such as Chinese medicine, natural medicinal ingredients complexity, effective ingredient is clear inadequately, the quality of Chinese medicine preparation often needs to control by each side such as crude drug (comprising medical material, extract or effective ingredient etc.), technology, quality standard, stability.The prescription flavour of a drug should be consistent with primary standard, but at present for some medicine because primary standard situation complexity, some flavour of a drug base is former indeterminate, whether be difficult to estimate the medical material that feeds intake consistent with primary standard, though it is basic former but cannot calibrate standard that the flavour of a drug in some medicine are clear and definite, particularly the medical material if any the special processing specification should feed intake by the requirement of primary standard unanimity when feeding intake in some drug prescriptions, to improve curative effect of medication or to reduce drug toxicity.
Summary of the invention
Technical problem to be solved by this invention provides a kind of Chinese medicine composition for the treatment of tumor.
Another technical problem to be solved of the present invention provides a kind of preparation method for the treatment of the Chinese medicine composition of tumor.
The present invention treats the Chinese medicine composition of tumor, be to make: Radix Curcumae 30~80g, Herba Agrimoniae 30~80g, Oletum Trogopterori 30~75g, Alumen 30~80g, Sal Nitri 30~80g, Resina Toxicodendri 8~30g, Fructus Aurantii 50~150g and Semen Strychni Pulveratum 15~50g by following materials of weight proportions medicine, Semen Strychni Pulveratum wherein is to be made by following weight proportion crude drug: Semen Strychni (processed): adjuvant is 0.1~5: 0.1~5, and described adjuvant is selected from one or more mixing in dextrin, starch, mannitol, microcrystalline Cellulose, the calcium bicarbonate.
The Chinese medicine composition of preferred therapeutic tumor of the present invention, be to make: Radix Curcumae 45~60g, Herba Agrimoniae 45~60g, Oletum Trogopterori 35~55g, Alumen 45~60g, Sal Nitri 35~55g, Resina Toxicodendri 12~25g, Fructus Aurantii 80~120g and Semen Strychni Pulveratum 25~40g by following materials of weight proportions medicine, Semen Strychni Pulveratum wherein is to be made by following weight proportion crude drug: Semen Strychni (processed): adjuvant is 0.5~2: 0.4~2, and described adjuvant is selected from one or more mixing in dextrin, starch, mannitol, the microcrystalline Cellulose.
The Chinese medicine composition of the treatment tumor of the best of the present invention, be to be made by following materials of weight proportions medicine: Radix Curcumae 54g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g, Semen Strychni Pulveratum are wherein made by following weight proportion crude drug: Semen Strychni (processed): starch is 1: 0.9~1.7.
The present invention treats the Chinese medicine composition of tumor, adopts following method preparation:
A, the Radix Curcumae of getting weight proportion, Herba Agrimoniae, Oletum Trogopterori, Alumen, Sal Nitri, Resina Toxicodendri, Fructus Aurantii, Semen Strychni Pulveratum are standby;
B, above eight flavors, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials, makes preparation.
The present invention preferably treats the Chinese medicine composition of tumor, adopts following method preparation:
A, the Radix Curcumae of getting weight proportion, Herba Agrimoniae, Oletum Trogopterori, Alumen, Sal Nitri, Resina Toxicodendri, Fructus Aurantii, Semen Strychni Pulveratum are standby;
B, above eight flavors, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 60~80% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 5-20 second, and 200-350 rev/min is stirred 0.5-2 minute, 150-180 down and rev/min stirred 5-30 minute down, shreds 10-20 minute under 1000-2000 rev/min; In the spray-dried granulator drying of granule below 80 ℃, get granule, make preparation.
The Chinese medicine composition of the further preferred treatment tumor of the present invention, adopt following method preparation:
A, the Radix Curcumae of getting weight proportion, Herba Agrimoniae, Oletum Trogopterori, Alumen, Sal Nitri, Resina Toxicodendri, Fructus Aurantii, Semen Strychni Pulveratum are standby;
B, above eight flavors, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol of 5 times of medicated powder amounts, the percolate to 4 times of medical material amounts of collection; Medicinal residues and Herba Agrimoniae decoct with water 2 times, the decocting that adds for the first time 10 times of amounts of medical material boiled 1 hour, the decocting that adds for the second time 8 times of amounts of medical material boiled 40 minutes, and collecting decoction filters, after percolate reclaims ethanol, merge with above-mentioned filtrate, it is the thick paste of 1.18-1.22 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, after the drying, add Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, get mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 10 seconds, and 270 rev/mins are stirred 1 minute, 170 rev/mins down and stirred 10-20 minute down, 1500 rev/mins of choppings 10-20 minute down; In the spray-dried granulator drying of granule below 80 ℃, get granule, make preparation.
The present invention treats the Chinese medicine composition of tumor, a kind of in capsule, tablet, granule, the pill.
Resina Toxicodendri among the present invention for forge Resina Toxicodendri, Fructus Aurantii is a stir-baked Fructus Aurantii in bran.
The present invention treats the Chinese medicine composition of tumor, and wherein said Semen Strychni Pulveratum adopts following method preparation:
A. it is standby to get weight proportion crude drug Semen Strychni (processed) and appropriate amount of auxiliary materials;
B. adopt single jar and grind the method for converting,, in the disposable then adding taper blending tank, mixed 30~90 minutes, promptly Semen Strychni (processed) and suitable adjuvant mix homogeneously.
The present invention treats in the Chinese medicine composition of tumor, and the content of strychnine is 0.78~0.82% in the described Semen Strychni Pulveratum.
The present invention treats in the Chinese medicine composition of tumor, the moisture of described Semen Strychni Pulveratum≤9.0%.
The present invention treats the preparation method of the Chinese medicine composition of tumor, and step is as follows:
A. get crude drug Semen Strychni (processed) 0.1~5 weight portion, adjuvant 0.1~5 weight portion; Described adjuvant is selected from one or more mixing in dextrin, starch, mannitol, microcrystalline Cellulose, the calcium bicarbonate; Adopt single jar and grind the method for converting, Semen Strychni (processed) and suitable adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 30~90 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B, get above eight flavors of weight proportion, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of auxiliary materials, and mixing is made granule, and drying is encapsulated, promptly.
The present invention preferably treats the preparation method of the Chinese medicine composition of tumor, and step is as follows:
A. get crude drug Semen Strychni (processed) 0.1~5 weight portion, adjuvant 0.1~5 weight portion; Described adjuvant is selected from one or more mixing in dextrin, starch, mannitol, microcrystalline Cellulose, the calcium bicarbonate; Adopt single jar and grind the method for converting, Semen Strychni (processed) and suitable adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 30~90 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B, above eight flavors, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 60~80% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 5-20 second, and 200-350 rev/min is stirred 0.5-2 minute, 150-180 down and rev/min stirred 5-30 minute down, shreds 10-20 minute under 1000-2000 rev/min; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
The present invention preferably treats the preparation method of the Chinese medicine composition of tumor, granulates with wet mixing pelletizer among the step b, mixes about 10 seconds, and 270 rev/mins are stirred 1 minute, 170 rev/mins down and stirred 10-20 minute down, 1500 rev/mins of choppings 10-20 minute down.
Contain Semen Strychni (processed) with strychnine (C in every capsules content that the present invention makes 12H 22N 2O 2) meter, should be 0.25~0.35mg.
Every capsules content that the present invention makes is 0.23 gram.
Adopt following method to concoct to crude drug among the present invention
[1] Radix Curcumae: choose decontamination, clean, the moistening section, it is dry below 80 ℃ to put into baking oven.
[2] Alumen, Sal Nitri: choose decontamination, pound into fragment, directly batching.
[3] Oletum Trogopterori, forge Resina Toxicodendri: choose decontamination, forge Resina Toxicodendri and pound into fragment, 80 ℃ of dryings of Oletum Trogopterori.
[4] Fructus Aurantii: choose decontamination, clean, the moistening section, it is dry below 60 ℃ to put into baking oven; Get wheat bran 9Kg and put into medicine roasting machine, be heated to and add clean medical material when smoldering and fry to complexion changed dark.
[5] Herba Agrimoniae: choose decontamination, cutting is cleaned, and it is dry below 80 ℃ to put into baking oven.
The raw material that the present invention treats the Chinese medicine composition of tumor form and preparation method in crude drug and supplementary product consumption when producing, can increase or reduce according to corresponding ratio, as large-scale production can be unit with the ton, small-scale production can be unit with the gram also, weight can increase or reduce, but the crude drug material weight proportion constant rate between each composition.
The present invention treats the Chinese medicine composition of tumor, has blood circulation promoting and blood stasis dispelling, pain relieving eliminating stagnation, heat-clearing and toxic substances removing, the effect of strengthening vital QI to eliminate pathogenic factors.The effect that tumor is had certain relief of symptoms, dwindles the tumor body, suppresses tumor growth, improves body immunity, prolongs patient's life.The present invention treats that Herba Agrimoniae, Oletum Trogopterori have activating blood circulation to dissipate blood stasis, tonify deficiency, analgesic effect in the Chinese medicine composition of tumor.By activating blood circulation to dissipate blood stasis, pain relieving eliminating stagnation, increase local blood circulation, the circulation of tumor tissues is increased, thereby improve the oxygen enrichment cell of tumor tissues, increase the sensitivity of tumor cell, thereby reach certain sensitization.Sal Nitri is gone into disappear heavily fortified point, Alumen of blood and is gone into gas and win wetly, and two medicine compatibilities disappear and become silted up by turbid.Radix Curcumae, Fructus Aurantii can promoting QI circulation for relieving depression, the eliminating stagnation painful abdominal mass that disappears, and strengthening vital QI to eliminate pathogenic factors has certain relief of symptoms effect to tumor, dwindle the tumor body, suppress growth of tumor, the dwindling of lump, the weary oxygen situation of tumor tissues reduces relatively, thereby has increased the oxygen enrichment cell relatively, has also improved the sensitivity of radiotherapy relatively.
The present invention treats the application of Chinese medicine composition in preparation treatment pulmonary carcinoma, hepatocarcinoma, colorectal cancer, breast carcinoma, the esophageal carcinoma, gastric cancer, nasopharyngeal carcinoma, malignant lymphoma, colon cancer, cervical cancer medicine of tumor.
The beneficial effect of pharmaceutical composition of the present invention is described below by the clinical observation result of pharmaceutical composition of the present invention (hereinafter to be referred as PINGXIAO JIA0NANG, obtaining according to embodiment 18 preparation methoies).
The efficacy analysis of PINGXIAO JIA0NANG treatment malignant tumor
(1) physical data
By to Zhongshan Univ. Cancer Cure Center, Jiangsu Prov. Tumour Hospital, Sichuan Tumor Hospiatal, Affiliated Hospital of Nantong Medical College, hospital general, Wuhan, the military region, Guangzhou, the People's Hospital, Qinghai Province, No.9 People's Hospital Attached to Shanghai No.2 Medical Univ, Zhongshan affiliated hospital of shanghai medical university, the attached First Academy of Chengdu University of Traditional Chinese Medicine, 20 tame clinical hospitals such as Tumour Hospital, Hubei Prov. participate in clinical observation, observe case load 1703 examples altogether, wherein treatment group (chemotherapy or radiotherapy+PINGXIAO JIA0NANG) 466 examples, matched group (simple chemotherapy or radiotherapy) 449 examples use PINGXIAO JIA0NANG not establish patient's 788 examples of treatment of control group.Treatment is organized among the 466 routine patients, comprises the 339 routine patients that carry out chemotherapy and carries out radiotherapy 127 routine patients.Among the matched group 449 routine patients, comprise the 324 routine patients that carry out chemotherapy and carry out radiotherapy 125 routine patients.Use PINGXIAO JIA0NANG but do not establish among the 788 routine patients of controlled observation, comprise 88 routine head and neck cancer patients, the immunity and the survival rate of carrying out 30 routine cancers in digestive system disease patients of chemotherapeutic treatment of carrying out chemotherapeutic treatment 60 routine patients with lung cancer, carrying out chemotherapeutic treatment, carry out radiocurable 610 routine survival rates and observe.Above patient's age, sex, by stages, base case such as treatment means all carried out statistical procedures, result's there are no significant difference all has comparability between two groups.
(2) result of study
The efficacy analysis of 1 PINGXIAO JIA0NANG combined with chemotherapy and radiotherapy in the treatment advanced lung cancer
To 353 routine patients with lung cancer, wherein patients undergoing chemotherapy 224 examples comprise treatment group (chemotherapy+PINGXIAO JIA0NANG) 124 examples, matched group (simple chemotherapy) 100 examples; Radiotherapy patient 69 examples comprise treatment group (radiotherapy+PINGXIAO JIA0NANG) 34 examples, matched group (radiation alone) 35 examples; Take the patient of PINGXIAO JIA0NANG group 60 examples merely, observe, situation is as follows:
1.1 observe 224 routine patients undergoing chemotherapies, wherein 124 examples are organized in treatment, matched group 100 examples, and its general curative effect sees Table 1.
Table 1 224 routine patients with lung cancer chemotherapeutic efficacy situations are n (%) relatively
As can be seen from the above table, accepting relatively has significant difference between two groups of patients with lung cancer general curative effects of chemotherapeutic treatment, and P<0.01 shows that treatment group general curative effect obviously is better than matched group.
1.2 observe 69 routine radiotherapy patients, 34 examples are organized in treatment, matched group 35 examples, and its general curative effect sees Table 2.
Table 2 69 routine patients with lung cancer radiotherapy effect situations are n (%) relatively
Figure G2009100089160D00052
Figure G2009100089160D00061
As can be seen from the above table, accepting relatively has significant difference between radiocurable two groups of patients with lung cancer general curative effects, and P<0.01 shows that treatment group general curative effect obviously is better than matched group.
1.3 60 examples are not established contrast, use PINGXIAO JIA0NANG treatment middle and advanced stage nonsmall-cell lung cancer patient's recent symptom curative effect to observe separately, its symptom curative effect judging standard is: the basic disappearance: treatment back transference cure, integration reduce to zero; Produce effects: partial symptoms disappears, and integration reduces more than 2/3; Effectively: symptom takes a turn for the better, and integration reduces by 1/3~2/3; Invalid: as not have obviously and improve, the constant or reduction less than 1/3 of integration.Observed result sees Table 3.
Table 3 60 examples are used the patients with lung cancer symptom therapeutic evaluation of PINGXIAO JIA0NANG separately
Figure G2009100089160D00062
As can be seen from the above table, use PINGXIAO JIA0NANG to have the obvious effect that improves the patients with lung cancer symptom separately, the effective percentage of symptoms such as it improves, and patients with lung cancer heating, gas are tight, cough, chest pain and spitting of blood is all above 80%.
1.4 the leukopenia situation to 65 routine lung cancer chemotherapy patients is observed, and the results are shown in Table 4.
The leukopenia situation compares (unit: * 10 after the table 4 65 routine patients with lung cancer chemotherapy 9/ L)
As can be seen from the above table, the fit applications PINGXIAO JIA0NANG can be impelled the leukocytic recovery of patients with lung cancer, and it improves chemotherapy and causes that the leukopenic effect of patients with lung cancer obviously is better than matched group.
1.5 life quality (Ka Shi scoring) situation to 109 routine lung cancer chemotherapy patients is observed, and the results are shown in Table 5.
Table 5 109 routine lung cancer chemotherapy patients' life quality (Ka Shi scoring) relatively
Figure G2009100089160D00064
Figure G2009100089160D00071
As can be seen from the above table, chemotherapy can impel the patients with lung cancer life quality to descend, but chemotherapy fit applications PINGXIAO JIA0NANG can be kept the life quality of patients with lung cancer.
1.6 the survival rate situation to 50 routine lung cancer chemotherapy patients has been carried out follow-up observation, the results are shown in Table 6.
Table 6 50 routine patients with lung cancer survival rate behind chemotherapeutic treatment compares
Figure G2009100089160D00072
As can be seen from the above table, treatment group and the survival rate in 1 year of matched group patients with lung cancer are respectively 80.0%, 73.3%; Treatment group and the survival rate in 2 years of matched group are respectively 54.2%, 33.3%, and the survival rate of treatment group 1 year and 2 years all is higher than matched group.
1.7 109 routine patients with lung cancer immunologic function indexs are observed, the results are shown in Table 7.
Immune indexes variation comparison before and after the table 7 109 routine patients with lung cancer chemotherapy (x ± s)
Figure G2009100089160D00073
As can be seen from the above table, chemotherapy fit applications PINGXIAO JIA0NANG has the effect that improves IgM and LCT, points out the effect of the humoral immune function that improves.
Observe 1.8 69 examples are carried out the total white blood cells variation and the T lymphocyte of the patients with lung cancer of radiotherapy in the treatment, the results are shown in Table 8,9.
The total white blood cells variation comparison behind radiotherapy of table 8 69 routine patients with lung cancer (x ± s)
Figure G2009100089160D00081
The T lymphocyte comparison behind radiotherapy of table 9 69 routine patients with lung cancer (x ± s)
Figure G2009100089160D00082
As can be seen from the above table, chemotherapy fit applications PINGXIAO JIA0NANG has the minimizing effect that stops leukocyte count and improves the lymphocytic effect of T, the effect of pointing out the cellular immune function that improves.
1.9 the accumulation situation of using each cycle toxicity of chemotherapeutic treatment patients with lung cancer is compared, and the treatment group is totally 146 cycles, in 153 cycles of matched group, the results are shown in Table 10.
Toxicity relatively after table 10 treatment group and the treatment of control group
Figure G2009100089160D00083
Figure G2009100089160D00091
As can be seen from the above table, PINGXIAO JIA0NANG add infringement such as the leukocyte, platelet, liver function of chemotherapy group all than simple chemotherapy group for light, prompting chemotherapy fit applications PINGXIAO JIA0NANG has certain Attenuation.But, there is not significant difference between two groups of aspects such as cardiac toxicity at digestive tract reaction.
2 PINGXIAO JIA0NANG cooperate radiotherapy nasopharyngeal carcinoma patient efficacy analysis
120 routine nasopharyngeal carcinoma patients are used radiotheraping method treat, wherein treatment group (radiotherapy fit applications PINGXIAO JIA0NANG) 60 examples, matched group (radiation alone) 60 examples, the observation situation is as follows:
2.1 observe 120 routine patients, wherein 60 examples are organized in treatment, matched group 60 examples, and its general curative effect sees Table 11.
Table 11 120 routine nasopharyngeal carcinoma patient's curative effect situations are n (%) relatively
Figure G2009100089160D00092
As can be seen from the above table, to carrying out between two groups of radiocurable nasopharyngeal carcinoma patients relatively there was no significant difference of general curative effect, P>0.05.
2.2 to 60 routine nasopharyngeal carcinoma patients, the influence of hepatic and renal function is observed behind radiotherapy, the results are shown in Table 12.
Compare before and after table 12 60 routine nasopharyngeal carcinoma patient's Liver and kidney merit treatments (x ± s)
Figure G2009100089160D00093
As can be seen from the above table, to relatively there are no significant the front and back of carrying out hepatic and renal function between two groups of radiocurable nasopharyngeal carcinoma patients difference, P>0.05.
2.3 reaction is observed to the acute radiation behind 120 routine nasopharyngeal carcinoma patient's radiotherapies, the results are shown in Table 13.
Table 13 liang group acute radiation reaction (when radiotherapy finishes)
Figure G2009100089160D00094
Figure G2009100089160D00101
As can be seen from the above table, to the comparison of carrying out acute radiation reaction between two groups of radiocurable nasopharyngeal carcinoma patients there are no significant difference, P>0.05.
2.4 survival rate
60 routine nasopharyngeal carcinoma patients have been carried out following up a case by regular visits to of 3 annual survival rates, and 3 annual survival rates of treatment group as a result and matched group are respectively 73.3% and 63.3%, and the treatment group is a little more than matched group.
The efficacy analysis of 3 PINGXIAO JIA0NANG combined with chemotherapy treatment colorectal cancer
63 routine PATIENTS WITH LARGE BOWEL treatment with chemotherapy methods are treated, wherein treatment group (chemotherapy fit applications PINGXIAO JIA0NANG) 33 examples, matched group (simple chemotherapy) 30 examples, the observation situation is as follows:
3.1 to 63 routine PATIENTS WITH LARGE BOWEL efficacy analysis, its total effects sees Table 14.
Table 14 63 routine PATIENTS WITH LARGE BOWEL radiotherapy effect situations are n (%) relatively
Figure G2009100089160D00102
As can be seen from the above table, to the there was no significant difference relatively of general curative effect between two groups of the PATIENTS WITH LARGE BOWEL of carrying out chemotherapy, P>0.05.
3.2 the comparison to the clinical therapeutic effect of syndrome of 63 routine PATIENTS WITH LARGE BOWEL the results are shown in Table 15.
The clinical therapeutic effect of syndrome situation of table 15 63 routine PATIENTS WITH LARGE BOWEL is n (%) relatively
Figure G2009100089160D00103
As can be seen from the above table, clinical syndrome between two groups of the PATIENTS WITH LARGE BOWEL of carrying out chemotherapy is improved situation relatively significant difference, P<0.01, and the symptom that prompting fit applications PINGXIAO JIA0NANG is improved patients undergoing chemotherapy obviously is better than simple chemotherapy group.
3.3 the comparison to 63 routine PATIENTS WITH LARGE BOWEL life quality curative effects the results are shown in Table 16.
Table 16 63 routine PATIENTS WITH LARGE BOWEL life quality situations of change are n (%) relatively
Figure G2009100089160D00104
As can be seen from the above table, significant difference relatively arranged to what life quality between two groups of the PATIENTS WITH LARGE BOWEL of carrying out chemotherapy changed, P<0.05, prompting fit applications PINGXIAO JIA0NANG has the effect that improves the patients undergoing chemotherapy life quality and obviously is better than simple chemotherapy group.
3.4 the comparison to main side effects after the 63 routine PATIENTS WITH LARGE BOWEL chemotherapy the results are shown in Table 17.
Table 17 63 routine PATIENTS WITH LARGE BOWEL chemotherapy toxic side effects relatively
As can be seen from the above table, toxicity between two groups of the PATIENTS WITH LARGE BOWEL of carrying out chemotherapy is compared, use PINGXIAO JIA0NANG when finding chemotherapy and can obviously alleviate nausea and vomiting, alopecia, diarrhoea and the leukopenic effect that chemotherapy causes.
The efficacy analysis of 4 PINGXIAO JIA0NANG combined with chemotherapy treatment breast carcinoma
Observe patient with breast cancer's 237 examples altogether, wherein 150 routine patients' general curative effect is evaluated, the leukocyte count situation of change of patient after the 87 routine chemotherapy is observed, the result is as follows:
4.1 in 150 routine patient with breast cancers, treatment group (chemotherapy fit applications PINGXIAO JIA0NANG) 80 examples, matched group (simple chemotherapy) 70 examples, its general curative effect sees Table 18.
Table 18 150 routine patient with breast cancer's curative effect situations are n (%) relatively
Figure G2009100089160D00112
As can be seen from the above table, to the there was no significant difference relatively of general curative effect between two groups of the patient with breast cancers that carry out chemotherapy, P>0.05.
4.2 in 87 routine patient with breast cancers, treatment group (chemotherapy fit applications PINGXIAO JIA0NANG) 45 examples, matched group (simple chemotherapy) 42 examples, the leukocyte situation of change sees Table 19 before and after its treatment.
WBC dynamic change situation before and after table 19 87 routine patient with breast cancers treat (x ± s)
As can be seen from the above table, the WBC number is treated preceding obvious reduce (P<0.05) after the simple chemotherapy of patient with breast cancer, and chemotherapy cooperates should have PINGXIAO JIA0NANG to help leukocytic recovery, and from the 3rd week, leukocyte recovery all around approaching normal (P>0.05).WBC number average value relatively recovers obviously to be better than matched group from second all begin treatment group leukocyte between two groups, and the prompting PINGXIAO JIA0NANG has the prevention leukopenia and promotes the function that leukocyte recovers.
The efficacy analysis of 5 PINGXIAO JIA0NANG combined with chemotherapy treatment head and neck cancer
Accepted intravenous chemotherapy, wherein male 51 examples, women 37 examples, 20~76 years old age, The median age 45 years old through squamous cell carcinoma of the head and neck patient's 88 examples that pathology is confirmed.Carcinoma of maxillary sinus 22 examples wherein, oral cancer 28 examples, lip cancer 6 examples, laryngeal carcinoma 16 examples, nasopharyngeal carcinoma 16 examples.Give DDP20mg/m 2, 5-FU500mg/m 2, vein splashed in the 1st~5 day, and cooperated 6/time of PINGXIAO JIA0NANG, and oral, every day three times, 21 days is one-period, all gives for 2 cycles.In chemotherapy process, other Chinese and Western cancer therapy drug and immune formulation is used in nonjoinder, but can merge the use Bendectin, and chemotherapeutic period is advised polydipsia water, gives aquation and diuretic.After finishing, two cycle chemotherapy carry out therapeutic evaluation.The result is alleviated 10 examples fully, and part is alleviated 41 examples, stablizes 30 examples, worsens 7 examples, and total effective rate is 58.0%.
The observation of the 6 pairs of malignant tumor curative effects and toxic and side effects
6.1 to 118 example digestion is that malignant tumor patient (wherein the esophageal carcinoma 41 examples, gastric cancer 50 examples, 50 examples, primary hepatocarcinoma 5 examples, colon cancer 22 examples) has carried out life quality and chemotherapy toxic side effect is observed, observed result sees Table 20,21.
Table 20 118 routine malignant tumor patient life quality situations of change are n (%) relatively
Figure G2009100089160D00121
As can be seen from the above table, significant difference relatively arranged to what life quality between two groups of the malignant tumor patients that carry out chemotherapy changed, P<0.01, prompting fit applications PINGXIAO JIA0NANG has the effect that improves the patients undergoing chemotherapy life quality and obviously is better than simple chemotherapy group.
Table 21 118 example digestion are that the toxicity of malignant tumor chemotherapy compares
Figure G2009100089160D00122
As can be seen from the above table, chemotherapy fit applications PINGXIAO JIA0NANG has nausea and vomiting, stomatitis, alopecia and the leukocyte that obvious reduction chemotherapeutics causes, the generation of hemoglobin reduction.
6.2 the immune indexes to 30 routine malignant tumor patients is observed, and the results are shown in Table 22.
Table 22 30 routine malignant tumor patients are treated the comparison (x ± s) of forward and backward IC-2, SIC-2R and TC subgroup
Figure G2009100089160D00131
As can be seen from the above table, treat back IC-2 content before treatment, before the SIC-2R expression is starkly lower than treatment, after the treatment of T cell subsets, CD 4, CD 4/ CD 8Before treatment, treatment back CD 8Before being starkly lower than treatment.The function of pointing out the PINGXIAO JIA0NANG tool to improve cellular immunization.
6.3 observation of curative effect to independent use PINGXIAO JIA0NANG treatment late malignant tumour patient 278 examples
Late malignant tumour patient 278 examples, breast carcinoma 25 examples wherein, hepatocarcinoma 51 examples, colorectal cancer 37 examples, cancer of pancreas 10 examples, pulmonary carcinoma 61, gastric cancer 35 examples, cervical cancer 15 examples, ovarian cancer 15 examples, nasopharyngeal carcinoma 15 examples, other tumor 14 examples.All cases or feelings evening and do not have operation and putting, treatment indication due to illness.Or because of family numbers of patients refusal operation and put, chemotherapy, the PINGXIAO JIA0NANG treatment of all selecting for use simple oral Xi'an Zhengda Pharmaceutical Co., Ltd. to produce.Each oral 6-8 grain, every day 3 times, 60 days is a course of treatment.The results are shown in Table 23.
Table 23 is used PINGXIAO JIA0NANG 278 routine late malignant tumour curative effects separately relatively
Figure G2009100089160D00132
By observation, dead 4 examples during the treatment, all the other cases are finished at least one course of therapy according to plan.Clinical symptom relief 195 examples account for 70.1%, and wherein pain relief person 125 examples account for 45.0% (125/278), effective 75 examples, and total effective rate 27.0% is stablized 158 examples, accounts for 56.8%.Karnofgky (KPS) scoring average out to 60.5 before the treatment, the KPS scoring of treatment back is 69.5, has increased by 9 fens, has 218 routine patients ' life qualities and improves, account for 78.4%, wherein appetite enhancer 154 examples account for 55.4%, sleep improver 137 examples, 49.3%, spiritual improvement person's 178 examples account for 64%.Tell person's 15 examples of feeling sick during the treatment, account for 5.4%, vomiter's 5 examples account for 1.8%, uncomfortable person's 30 examples that upper abdomen is slight account for 10.8%, advise patient to adhere to taking medicine after meal, perhaps suitable decrement, constipation person's 25 examples account for 9.0%, do not find hepatic and renal function injure, none example drug withdrawal because of drug side effect.
7 survival rate situation analysis
7.1, be divided into treatment group (radiotherapy adds the PINGXIAO JIA0NANG group) and matched group (radiotherapy alone) to 610 routine malignant tumor patients.Observe 1 year and survival rate of its various cancers kind, it the results are shown in Table 24.
Table 24 610 routine radiotherapy tumor patient 1,3 annual survival rates relatively
Figure G2009100089160D00141
As can be seen from the above table, 610 routine tumor patient 1 annual survival rates are respectively 75.7%, 65.6%; 3 annual survival rates are respectively 59.5%, 46.1%, and the survival rate in 1 year, 3 years of treatment group all is higher than matched group.From single sick kind situation, no matter the survival rate in 1 year, 3 years of use in conjunction PINGXIAO JIA0NANG all is higher than and only carries out radiocurable survival rate behind pulmonary carcinoma, esophageal carcinoma, breast carcinoma, cervical cancer and the nasopharyngeal carcinoma patient radiotherapy.
7.2 84 colon cancer patients are carried out chemotherapy, observe its survival rate situation, the results are shown in Table 25.
1,3,5 annual survival rates relatively after table 25 84 routine colon cancer patient's chemotherapy
Figure G2009100089160D00142
Figure G2009100089160D00151
As can be seen from the above table, two groups 1 annual survival rate is respectively 97.5%, 90.9% after treatment group and the matched group 84 routine colon cancer patient's chemotherapy; 3 annual survival rates are respectively 85.0%, 63.0%; 5 annual survival rates are respectively 77.5%, 47.7%, no matter the survival rate in 1 year, 3 years, or 5 annual survival rates, the treatment group all is higher than matched group.
By medical institutions of family surplus 20 routine tumor patient surplus 1700 has been carried out clinical observation on the therapeutic effect, its observational technique is that simple chemotherapy, radiation alone, PINGXIAO JIA0NANG combined with chemotherapy, PINGXIAO JIA0NANG cooperate radiotherapy, use PINGXIAO JIA0NANG etc. separately, in secular process of clinical application, we realize this kind following several characteristics:
1 anticancer spectrum is wider, and different types of cancer patient is all had the good anticancer effect.Common malignancy such as the pulmonary carcinoma that this observation relates to, hepatocarcinoma, colorectal cancer, breast carcinoma, the esophageal carcinoma, gastric cancer, nasopharyngeal carcinoma, malignant lymphoma all demonstrate certain anticancer therapeutic.
2 alleviate the clinical symptoms of cancer patient, physical strength reinforcing, and prolongation is put, chemotherapy cycles, improves patient's life quality.Under observation as can be seen, use the clinical symptoms of the alleviation patients with advanced cancer that PINGXIAO JIA0NANG can be in various degree, improve the life quality of tumor patient.As the pain due at ameliorate tumor, alleviate and block aspects such as symptom, improving appetite, physical strength reinforcing, all have certain effect.
3 alleviate the toxicity of patients undergoing chemotherapy, improve the toleration of patients undergoing chemotherapy.Observed result shows PINGXIAO JIA0NANG and chemotherapeutics and usefulness, can obviously alleviate the caused toxicity of chemotherapeutics, prolongs patient's chemotherapy cycles, strengthens the toleration that tumor patient carries out chemotherapy.
4 improve immunologic function, strengthen patient's resistance against diseases, promote patient's early recovery.Observed result display application PINGXIAO JIA0NANG can improve immunological function of cancer patients, observe the decline that simple chemotherapy or radiotherapy all can cause patient's immune level, if fit applications PINGXIAO JIA0NANG in the process of chemotherapy or radiotherapy, but the degree that the ameliorate tumor patient immune function descends, the prompting PINGXIAO JIA0NANG has the effect that improves immunologic function or stops tumor patient to cause the effect of immunologic function degression owing to chemotherapeutics, thereby strengthen the resistance against diseases of tumor patient, promote rehabilitation of patients.
5 improve the survival rate of tumor patient.To widely applying the tumor patient of PINGXIAO JIA0NANG, observe the survival rate that one is regularly put, can find that PINGXIAO JIA0NANG has the effect of tangible raising tumor patient survival rate.
6 untoward reaction are very low, and are safe and reliable.PINGXIAO JIA0NANG is not observed in clinical practice has tangible influence to the heart, liver, kidney and blood system, does not also observe the generation of adverse events.
The specific embodiment
Further set forth the preparation method of medicine of the present invention by the following examples.
Embodiment 1
A. get Semen Strychni (processed) 0.1kg, dextrin 0.1kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and dextrin mix homogeneously, in the disposable then adding taper blending tank, mixed 30 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B, the Radix Curcumae 80g that gets weight proportion, Herba Agrimoniae 80g, Oletum Trogopterori 75g, Alumen 80g, Sal Nitri 80g, Resina Toxicodendri 30g, Fructus Aurantii 150g and Semen Strychni Pulveratum 50g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and behind the percolate recovery ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 5 seconds, and 200 rev/mins are stirred 2 minutes, 150 rev/mins down and stirred 30 minutes down, 1000 rev/mins of choppings 20 minutes down; In the spray-dried granulator drying of granule below 80 ℃, make granule, incapsulate.
Embodiment 2
A. get Semen Strychni (processed) 5kg, dextrin 5kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and dextrin mix homogeneously, in the disposable then adding taper blending tank, mixed 90 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B, the Radix Curcumae 30g that gets weight proportion, Herba Agrimoniae 30g, Oletum Trogopterori 30g, Alumen 30g, Sal Nitri 30g, Resina Toxicodendri 8g, Fructus Aurantii 50g and Semen Strychni Pulveratum 15g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with 60% ethanol, granulates with wet mixing pelletizer, mixes about 10 seconds, and 270 rev/mins are stirred 1.5 minutes, 200 rev/mins down and stirred 15 minutes down, 1000 rev/mins of choppings 10 minutes down; In the spray-dried granulator drying of granule below 80 ℃, make granule, incapsulate.
Embodiment 3
A. get Semen Strychni 1.5kg, dextrin 2.5kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and dextrin mix homogeneously, in the disposable then adding taper blending tank, mixed 60 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B, the Radix Curcumae 45g that gets weight proportion, Herba Agrimoniae 45g, Oletum Trogopterori 35g, Alumen 45g, Sal Nitri 35g, Resina Toxicodendri 12g, Fructus Aurantii 80g and Semen Strychni Pulveratum 25g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and behind the percolate recovery ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 20 seconds, and 350 rev/mins are stirred 0.5 minute, 180 rev/mins down and stirred 5 minutes down, 2000 rev/mins of choppings 10 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate promptly.
Embodiment 4
A. get Semen Strychni (processed) 0.1kg, starch 5kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and starch mix homogeneously, in the disposable then adding taper blending tank, mixed 30 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B, the Radix Curcumae 60g that gets weight proportion, Herba Agrimoniae 60g, Oletum Trogopterori 55g, Alumen 60g, Sal Nitri 55g, Resina Toxicodendri 25g, Fructus Aurantii 120g and Semen Strychni Pulveratum 40g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with 55% ethanol, granulates with wet mixing pelletizer, mixes about 5 seconds, and 300 rev/mins are stirred 1 minute, 180 rev/mins down and stirred 2 minutes down, 1500 rev/mins of choppings 10 minutes down; In the spray-dried granulator drying of granule below 70 ℃, get granule, incapsulate promptly.
Embodiment 5
A. get Semen Strychni (processed) 0.2kg, starch 0.1kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and starch mix homogeneously, in the disposable then adding taper blending tank, mixed 40 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 54g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g, more than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 60% ethanol, the percolate to 4 times of medical material amounts of collection; Medicinal residues and Herba Agrimoniae decoct with water 2 times, add 10 times of amounts of water for the first time, decoct 1 hour; Add 8 times of amounts of water the second time, decocted 40 minutes, and collecting decoction filters, and after percolate reclaims ethanol, merges with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 8 seconds, and 250 rev/mins are stirred 1.5 minutes, 160 rev/mins down and stirred 15 minutes down, 1200 rev/mins of choppings 15 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
Embodiment 6
A. get Semen Strychni (processed) 0.5kg, starch 5kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and starch mix homogeneously, in the disposable then adding taper blending tank, mixed 40 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 54g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g, more than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with 60% ethanol, granulates with wet mixing pelletizer, mixes about 5 seconds, and 250 rev/mins are stirred 3 minutes, 180 rev/mins down and stirred 10 minutes down, 1500 rev/mins of choppings 10 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate promptly.。
Embodiment 7
A. get Semen Strychni (processed) 5kg, starch 4kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and starch mix homogeneously, in the disposable then adding taper blending tank, mixed 35 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 50g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 50g, Sal Nitri 50g, Resina Toxicodendri 18g, Fructus Aurantii 80g and Semen Strychni Pulveratum 36g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials, makes granule.
Embodiment 8
A. get Semen Strychni (processed) 1kg; Each 0.25kg is standby for dextrin, starch, mannitol, microcrystalline Cellulose and calcium bicarbonate; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 60 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 30g, Herba Agrimoniae 30g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 30g, Resina Toxicodendri 18g, Fructus Aurantii 60g and Semen Strychni Pulveratum 26g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with 75% ethanol, granulates with wet mixing pelletizer, mixes about 5 seconds, and 300 rev/mins are stirred 2.5 minutes, 250 rev/mins down and stirred 5 minutes down, 1000 rev/mins of choppings 5 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate promptly.
Embodiment 9
A. it is standby to get each 0.45kg of Semen Strychni (processed) 0.6kg, starch, mannitol and microcrystalline Cellulose; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 50 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 34g, Herba Agrimoniae 34g, Oletum Trogopterori 25g, Alumen 54g, Sal Nitri 34g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 80% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 20 seconds, and 300 rev/mins are stirred 2 minutes, 180 rev/mins down and stirred 30 minutes down, 2000 rev/mins of choppings 10 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
Embodiment 10
A. get Semen Strychni (processed) 1kg, mannitol 0.8kg, microcrystalline Cellulose 0.6kg is standby; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 45 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 45g, Herba Agrimoniae 60g, Oletum Trogopterori 35g, Alumen 60g, Sal Nitri 35g, Resina Toxicodendri 12g, Fructus Aurantii 120g and Semen Strychni Pulveratum 25g, more than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 10 seconds, and 150 rev/mins are stirred 2.5 minutes, 180 rev/mins down and stirred 10 minutes down, 1000 rev/mins of choppings 2 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate promptly.
Embodiment 11
A. get Semen Strychni (processed) 0.2kg, dextrin 0.2kg; Adopt single jar and grind the method for converting, Semen Strychni (processed) and dextrin mix homogeneously, in the disposable then adding taper blending tank, mixed 45 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 60g, Herba Agrimoniae 45g, Oletum Trogopterori 55g, Alumen 45g, Sal Nitri 35g, Resina Toxicodendri 25g, Fructus Aurantii 80g and Semen Strychni Pulveratum 40g, more than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 75% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with 55% ethanol, granulates with wet mixing pelletizer, mixes about 6 seconds, and 200 rev/mins are stirred 2 minutes, 150 rev/mins down and stirred 5 minutes down, 1000 rev/mins of choppings 10 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
Embodiment 12
A. get Semen Strychni (processed) 0.4kg, dextrin 0.1kg, calcium bicarbonate 0.5kg is standby; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 70 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 40g, Herba Agrimoniae 40g, Oletum Trogopterori 50g, Alumen 80g, Sal Nitri 30g, Resina Toxicodendri 30g, Fructus Aurantii 150g and Semen Strychni Pulveratum 15g, more than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with 60% ethanol, granulates with wet mixing pelletizer, mixes about 5 seconds, and 300 rev/mins are stirred 1 minute, 160 rev/mins down and stirred 8 minutes down, 1500 rev/mins of choppings 15 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
Embodiment 13
A. get Semen Strychni (processed) 2kg, starch 3kg, the standby employing of calcium bicarbonate 2kg is ground the method for converting for single jar, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixes 80 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 80g, Herba Agrimoniae 30g, Oletum Trogopterori 30g, Alumen 80g, Sal Nitri 80g, Resina Toxicodendri 30g, Fructus Aurantii 100g and Semen Strychni Pulveratum 20g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, and after the drying, adding Semen Strychni Pulveratum, above-mentioned fine powder and substrate are an amount of, make drop pill.
Embodiment 14
A. get Semen Strychni (processed) 3kg, each 2kg is standby for dextrin and starch; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 55 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 54g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g, more than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials, makes pill.
Embodiment 15
A. get Semen Strychni (processed) 0.5kg, dextrin, starch, each 0.4kg is standby for microcrystalline Cellulose; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 75 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 54g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials, makes granule.
Embodiment 16
A. get Semen Strychni (processed) 0.2kg, dextrin, each 0.8kg is standby for starch; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 85 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 40g, Herba Agrimoniae 40g, Oletum Trogopterori 35g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 120g and Semen Strychni Pulveratum 36g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and right amount of auxiliary materials; Is binding agent with mixed powder with 58% ethanol, granulates with wet mixing pelletizer, mixes about 12 seconds, and 280 rev/mins are stirred 0.5-2 minute, 150-180 down and rev/min stirred 25 minutes down, 1300 rev/mins of choppings 12 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
Embodiment 17
A. get Semen Strychni (processed) 0.5kg, starch, each 0.3kg is standby for microcrystalline Cellulose; Adopt single jar and grind the method for converting, Semen Strychni (processed) and above-mentioned adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 60 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get above eight flavors of Radix Curcumae 54g, Herba Agrimoniae 45g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 45g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of auxiliary materials, and mixing is made granule, and drying is encapsulated, promptly
Embodiment 18
A. get Semen Strychni (processed) 1kg, starch 0.9kg is standby; Adopt single jar and grind the method for converting, Semen Strychni (processed) and starch mix homogeneously, in the disposable then adding taper blending tank, mixed 60 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 54g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 54g, forge Resina Toxicodendri 18g, Fructus Aurantii (parched with bran) 90g and Semen Strychni Pulveratum 36g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol of 5 times of medicated powder amounts, the percolate to 4 times of medical material amounts of collection; Medicinal residues and Herba Agrimoniae decoct with water 2 times, the decocting that adds for the first time 10 times of amounts of medical material boiled 1 hour, the decocting that adds for the second time 8 times of amounts of medical material boiled 40 minutes, and collecting decoction filters, after percolate reclaims ethanol, merge with above-mentioned filtrate, it is the thick paste of 1.18-1.22 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, after the drying, add Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, get mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 10 seconds, and 270 rev/mins are stirred 1 minute, 170 rev/mins down and stirred 10-20 minute down, 1500 rev/mins of choppings 10-20 minute down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
Embodiment 19
A. get Semen Strychni (processed) 1kg, starch 1.7kg is standby; Adopt single jar and grind the method for converting, Semen Strychni (processed) and starch mix homogeneously, in the disposable then adding taper blending tank, mixed 90 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get above eight flavors of Radix Curcumae 60g, Herba Agrimoniae 54g, Oletum Trogopterori 50g, Alumen 60g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 80g and Semen Strychni Pulveratum 30g, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of auxiliary materials, and mixing is made granule, and drying is encapsulated, promptly.
Embodiment 20
A. get Semen Strychni (processed) 1kg, starch 1kg is standby; Adopt single jar and grind the method for converting, Semen Strychni (processed) and starch mix homogeneously, in the disposable then adding taper blending tank, mixed 75 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B. get Radix Curcumae 70, Herba Agrimoniae 70g, Oletum Trogopterori 60g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 25g, Fructus Aurantii 90g and Semen Strychni Pulveratum 30g; More than eight the flavor, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 10 seconds, and 270 rev/mins are stirred 1 minute, 170 rev/mins down and stirred 10 minutes down, 1500 rev/mins of choppings 15 minutes down; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.

Claims (12)

1. Chinese medicine composition for the treatment of tumor, its feature is made by following materials of weight proportions medicine: Radix Curcumae 30~80g, Herba Agrimoniae 30~80g, Oletum Trogopterori 30~75g, Alumen 30~80g, Sal Nitri 30~80g, Resina Toxicodendri 8~30g, Fructus Aurantii 50~150g and Semen Strychni Pulveratum 15~50g, Semen Strychni Pulveratum wherein is to be made by following weight proportion crude drug: Semen Strychni (processed): adjuvant is 0.1~5: 0.1~5, and described adjuvant is selected from one or more mixing in dextrin, starch, mannitol, microcrystalline Cellulose, the calcium bicarbonate.
2. the Chinese medicine composition of the described treatment tumor of claim 1, its feature is made by following materials of weight proportions medicine: Radix Curcumae 45~60g, Herba Agrimoniae 45~60g, Oletum Trogopterori 35~55g, Alumen 45~60g, Sal Nitri 35~55g, Resina Toxicodendri 12~25g, Fructus Aurantii 80~120g and Semen Strychni Pulveratum 25~40g, Semen Strychni Pulveratum wherein is to be made by following weight proportion crude drug: Semen Strychni (processed): adjuvant is 0.5~2: 0.4~2, and described adjuvant is selected from one or more mixing in dextrin, starch, mannitol, the microcrystalline Cellulose.
3. the Chinese medicine composition of the described treatment tumor of claim 2, its feature is made by following materials of weight proportions medicine: Radix Curcumae 54g, Herba Agrimoniae 54g, Oletum Trogopterori 45g, Alumen 54g, Sal Nitri 54g, Resina Toxicodendri 18g, Fructus Aurantii 90g and Semen Strychni Pulveratum 36g, Semen Strychni Pulveratum are wherein made by following weight proportion crude drug: Semen Strychni (processed): starch is 1: 0.9~1.7.
4. the Chinese medicine composition of the arbitrary described treatment tumor of claim 1~3 is characterized in that adopting following method preparation:
A, the Radix Curcumae of getting weight proportion, Herba Agrimoniae, Oletum Trogopterori, Alumen, Sal Nitri, Resina Toxicodendri, Fructus Aurantii, Semen Strychni Pulveratum are standby;
B, above eight flavors, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 60~80% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 5-20 second, and 200-350 rev/min is stirred 0.5-2 minute, 150-180 down and rev/min stirred 5-30 minute down, shreds 10-20 minute under 1000-2000 rev/min; In the spray-dried granulator drying of granule below 80 ℃, get granule, make preparation.
5. the Chinese medicine composition of the described treatment tumor of claim 4 is characterized in that adopting following method preparation:
A, the Radix Curcumae of getting weight proportion, Herba Agrimoniae, Oletum Trogopterori, Alumen, Sal Nitri, Resina Toxicodendri, Fructus Aurantii, Semen Strychni Pulveratum are standby;
B, above eight flavors, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 70% ethanol of 5 times of medicated powder amounts, and collection obtains the percolate of 4 times of medical material amounts; Medicinal residues and Herba Agrimoniae decoct with water 2 times, the decocting that adds for the first time 10 times of amounts of medical material boiled 1 hour, the decocting that adds for the second time 8 times of amounts of medical material boiled 40 minutes, and collecting decoction filters, after percolate reclaims ethanol, merge with above-mentioned filtrate, it is the thick paste of 1.18-1.22 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, after the drying, add Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, get mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 10 seconds, and 270 rev/mins are stirred 1 minute, 170 rev/mins down and stirred 10-20 minute down, 1500 rev/mins of choppings 10-20 minute down; In the spray-dried granulator drying of granule below 80 ℃, get granule, make preparation.
6. the Chinese medicine composition of the described treatment tumor of claim 4 is characterized in that said preparation is a kind of in capsule, tablet, granule, the pill.
7. the Chinese medicine composition of the arbitrary described treatment tumor of claim 1~3 is characterized in that described Semen Strychni Pulveratum adopts following method preparation:
A. it is standby to get weight proportion crude drug Semen Strychni (processed) and appropriate amount of auxiliary materials;
B. adopt single jar and grind the method for converting,, in the disposable then adding taper blending tank, mixed 30~90 minutes, promptly Semen Strychni (processed) and suitable adjuvant mix homogeneously.
8. the Chinese medicine composition of the described treatment tumor of claim 7 is characterized in that, the content of strychnine is 0.78~0.82% in the described Semen Strychni Pulveratum.
9. the preparation method of the Chinese medicine composition of the arbitrary described treatment tumor of claim 1~3 is characterized in that step is as follows:
A. get crude drug Semen Strychni (processed) 0.1~5 weight portion, adjuvant 0.1~5 weight portion; Described adjuvant is selected from one or more mixing in dextrin, starch, mannitol, microcrystalline Cellulose, the calcium bicarbonate; Adopt single jar and grind the method for converting, Semen Strychni (processed) and suitable adjuvant mix homogeneously, in the disposable then adding taper blending tank, mixed 30~90 minutes, it is standby to be prepared into Semen Strychni Pulveratum;
B, above eight flavors, Resina Toxicodendri, Oletum Trogopterori, Alumen, Sal Nitri are ground into fine powder; Radix Curcumae, Fructus Aurantii are ground into coarse powder, according to the percolation (appendix I O) under Chinese Pharmacopoeia fluid extract and the extractum item, are that solvent carries out percolation with 60~80% ethanol, the collection percolate; Medicinal residues and Herba Agrimoniae decoct with water 2 times, and collecting decoction filters, and after percolate reclaims ethanol, merge with above-mentioned filtrate, and concentrating under reduced pressure becomes thick paste, after the drying, adds Semen Strychni Pulveratum, above-mentioned fine powder and appropriate amount of starch, gets mixed powder; Is binding agent with mixed powder with the ethanol of 55-60%, granulates with wet mixing pelletizer, mixes about 5-20 second, and 200-350 rev/min is stirred 0.5-2 minute, 150-180 down and rev/min stirred 5-30 minute down, shreds 10-20 minute under 1000-2000 rev/min; In the spray-dried granulator drying of granule below 80 ℃, get granule, incapsulate.
10. the preparation method of the Chinese medicine composition of the described treatment tumor of claim 9; it is characterized in that, granulate with wet mixing pelletizer among the step b, mixed about 10 seconds; stir 1 minute, 170 rev/mins under 270 rev/mins and stirred 10-20 minute down, 1500 rev/mins were shredded 10-20 minute down.
11, according to the preparation method of the Chinese medicine composition of the described treatment tumor of claim 10, it is characterized in that, contain Semen Strychni (processed) with strychnine (C in every capsules content of making 12H 22N 2O 2) meter, should be 0.25~0.35mg.
12, the application of the arbitrary described pharmaceutical composition of claim 1-8 in preparation treatment pulmonary carcinoma, hepatocarcinoma, colorectal cancer, breast carcinoma, the esophageal carcinoma, gastric cancer, nasopharyngeal carcinoma, malignant lymphoma, colon cancer, cervical cancer medicine.
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